Joint Development Committee Clause Samples

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [*...

Joint Development Committee. The Parties will establish a joint development committee (“JDC” or “Joint Development Committee”) within 30 days after the Effective Date to oversee, coordinate, and discuss development of the Instrument and Cartridges as set forth in the applicable SOWs attached to this Agreement, and the Parties’ corresponding activities under this Agreement.

Joint Development Committee. Within one hundred eighty days (180) days from the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee”) to coordinate and oversee the development of the Licensed Product in the Territory.

Joint Development Committee. The Parties will form a joint development committee (the “JDC”) to serve as a forum for information exchange and discussion with respect to development and regulatory activities relating to Compounds and Products in the Field in the Territory.

Joint Development Committee. […***…] after the Effective Date, the Parties will form a joint development and regulatory committee (the “JDC”) to coordinate the overall strategy, plans, and responsibilities of the Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the Parties to review Development and regulatory matters pertaining to the Licensed Product in the Licensed Territory and outside the Licensed Territory, and to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]; (b) to review and approve the conduct by Mirati of any Development activities with respect to any Licensed Product in the Licensed Territory solely for use or sale outside the Licensed Territory, other than […***…]; (c) to review and approve the Development Plan, with the understanding that the Initial Development Plan has been approved by the Parties, and any material amendments or revisions thereto; (d) to review and coordinate forecasting and supply of BeiGene’s expected requirements of Drug Substance and Drug Product for Development purposes; 15 *** Confidential Treatment Requested (e) to review all material […***…]; (f) to provide a forum for discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the Licensed Product to be submitted to any Regulatory Authority […***…]; (h) to review and discuss […***…]; (i) to discuss and provide a forum for the exchange of pharmacovigilance and safety matters; (j) to provide a forum for discussion of and coordinate decisions related to […***…]; and (k) to discuss, review and approve any proposed publications and presentations by Mirati that includes the Clinical Data of BeiGene and to discuss and review any […***…], with the objective of protecting each Party’s Confidential Information and providing a reasonable opportunity for patent prosecution as appropriate prior to publication; and (l) to perform such other functions as the Parties may allocate to JDC in writing, where such functions are appropriate to further the purposes of this Agreement with respect to the Develo...

Joint Development Committee. Within [***] after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of one (1) representative of each Party, to guide the collaboration of the Parties under this Agreement and to oversee the exchange of information between the Parties with respect to the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC shall in particular: (a) provide a forum for the discussion of the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product; (b) oversee the transfer of Licensed Know-How and materials to Roivant under Section 2.4 (Initial Transfer of Know-How and Materials); and (c) provide a forum for Roivant to keep TheraVida reasonably informed regarding the Development of Licensed Products including the status of any Regulatory Filings, Regulatory approvals, or clinical trials. The JDC shall have only such powers as are expressly assigned to it in this Agreement, and such powers shall be subject to the terms and conditions of this Agreement. For clarity, the JDC shall primarily be advisory and provide a forum for information exchange, with Roivant having ultimate decision making authority to the extent any decisions must be made by the JDC; provided, however, that neither the JDC, nor Roivant in the exercise of its ultimate decision making authority, shall have any right, power or authority: (i) to determine any issue in a manner that would conflict with the express terms and conditions of this Agreement; or (ii) to modify or amend the terms and conditions of this Agreement. Upon the first approval by the FDA of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first), the JDC will cease to exist and the Parties will no longer have any obligations with respect to the JDC.

Joint Development Committee. Promptly after the Effective Date, the JSC shall establish a joint development committee (“JDC”). The JDC shall have primary responsibility for the matters set forth in Section 3.1.2(a) - 3.1.2(f) and 3.1.2(h) - 3.1.2(j), together with such other matters as are delegated to the JDC by the JSC.

Joint Development Committee. (a) No later than its initial meeting, the JSC shall establish a joint Development committee (the “Joint Development Committee” or “JDC”) which shall hold its initial meeting within fifteen (15) days of its establishment. At its first meeting, the JDC shall: (i) [***], and (ii) review, modify as necessary and recommend for approval to the JSC a Development Plan (including the Development Budget). The Illustrative Development Plan/Budget is an illustrative indication of the activities and the budget to be considered and addressed in the first Development Plan and shall not be binding on the Parties, the JSC or the JDC. Following its initial meeting, the JDC will meet in person, by teleconference or by video- teleconference at least [***] per [***] to [***]. (b) Without limiting the foregoing, the JDC shall be responsible for: (i) reviewing, consulting with the Parties on and modifying (as appropriate) the Development Plan including the Development Budget; (ii) recommending the Development Plan including the Development Budget (as modified) for approval by the JSC; (iii) communicating with the JCC regarding the interrelationship between Development activities and potential Commercialization; (iv) reviewing and monitoring the activities and progress against the Development Plan; (v) reviewing and monitoring the costs and expenses of Development against the Development Budget; (vi) finalizing the Product specifications for inclusion in the Regulatory Filings for the Territory and Regulatory Approvals and Pricing and Reimbursement Approvals for the Territory; and (vii) communicating with the Parties regarding all of the foregoing. For the avoidance of doubt, the CRO used for Clinical Trials shall be selected by Coherus, and such selection shall not be subject to the dispute escalation process under Section 3.1(d) (Decision-Making; Deciding Vote).

Joint Development Committee. Within thirty (30) days of the Effective Date of this Agreement, GenuPro and Licensee shall assemble a JDC. Initially, the JDC will be composed of at least two, but no more than four, representatives each from GenuPro or its Affiliates and Licensee. The initial members of the JDC will be those representatives the names of whom will be provided to the other Party within ten days after the Effective Date. Each Party will promptly notify the other Party in writing of any change in its appointed representatives. The chairperson of the JDC will be one of Licensee’s representatives.